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FRIDAY, Feb. 17, 2012
— Next week, the Food and Drug Administration is set
to review the safety and effectiveness of the controversial weight-loss
drug Qnexa, whose manufacturers, Vivius Inc., are pushing to make
Qnexa the first new FDA-approved weight-loss supplement since 1999.

The FDA originally reviewed Qnexa as
a treatment for weight loss in 2010, but turned it down over safety concerns,
including possible heart problems and an increased risk of birth defects. According to the Wall Street
Journal, other studies of one of Qnexa’s active
ingredients, topirmate, have suggested an increased birth-defect risk. In
response, Vivius initially proposed limiting the drug to men and women of
nonchild-bearing age.

After the initial rejection, the FDA
asked Vivus for an additional assessment of the drug’s potential harm
— a common practice in FDA drug proceedings — and now,
Vivus reports the drug is not only safe, but also effective in producing
significant weight loss. Next
week’s review of the drug will include data from a two-year clinical trial, as
opposed to only one year’s worth of data, which was what was reviewed in 2010. The
new clinical trial data found that the drug was successful in producing weight
loss during the first year of use, but that some participants did regain some
weight during the second year of the trial.

The 2010 rejection of Qnexa and
several other diet drugs thrust the FDA’s approval process for weight-loss
drugs into the spotlight at a time when obesity continues to be a nationwide
health crisis. In recent years, the agency has been particularly hesitant to
approve new treatments
because of missteps with past approvals, including most infamously, the diet
drug cocktail fen-phen, which was later found to cause potentially fatal
heart-valve problems.

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